search
Back to results

Assessing the Efficacy and Safety of DEXTENZA in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment

Primary Purpose

Retinal Detachment

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dextenza
Prednisolone Acetate
Sponsored by
Midwest Eye Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Retinal Detachment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pseudophakic
  • Retinal Detachment
  • Age 18 years and older
  • Scheduled for gas bubble repair and laser surgery following retinal detachment
  • Willing and able to comply with clinic visits and study related procedures
  • Willing and able to sign the informed consent form

Exclusion Criteria:

  • Patients under the age of 18.
  • Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
  • Active infectious systemic disease
  • Active infectious ocular or extraocular disease
  • Obstructed nasolacrimal duct in the study eye(s)
  • Hypersensitivity to dexamethasone
  • Patients being treated with immunomodulating agents in the study eye(s)
  • Patients being treated with immunosuppressants and/or oral steroids
  • Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator

Sites / Locations

  • Midwest Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intracanalicular Sustained Release Dexamethasone, 0.4 mg

topical prednisolone acetate 1%.

Arm Description

Intracanalicular dexamethasone insert contains 0.4 mg dexamethasone and is designed to provide a sustained and tapered release of therapeutic levels of dexamethasone to the ocular surface for up to 30 days for the reduction of post-surgical inflammation and pain associated with ocular surgery.

Outcomes

Primary Outcome Measures

Mean change in pain score
Average change in pain based on whats reported on the Ocular Pain Assessment
Post-op pain scores
Ocular Pain Assessment: Measured on a scale from 0-10 where 0 (minimum) is no pain and 10 (maximum) is extreme pain. High reported pain means a worse outcome.

Secondary Outcome Measures

Mean change in anterior chamber cell and flare score
Post op inflammation scores as measured on a scale of 0-4: Anterior Chamber Cell Count (Absence of cell to be defined as a grade of: 0-0.5, 4 being the maximum) and Anterior Chamber Flare Score (0 is the minimum, and 4 is the maximum). High reported cell and flare means a worse outcome.
Cystoid Macular Edema
Amount of central thickness macular swelling as measured by Optical Coherence Tomography (OCT)
Best Corrected Visual Acuity
As measured on ETDRS
Physician Ease of Dextenza insertion
The investigator will grade the level of ease of insertion of the intracanalicular insert on a 0 to 10-point (0 being the minimum and 10 being the maximum) scale with 0 being very easy insertion and 10 being very hard. Difficult insertion means a worse outcome.

Full Information

First Posted
July 6, 2020
Last Updated
August 14, 2023
Sponsor
Midwest Eye Institute
Collaborators
Ocular Therapeutix, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04464629
Brief Title
Assessing the Efficacy and Safety of DEXTENZA in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment
Official Title
Assessing the Efficacy and Safety of DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert, When Placed Within the Lower Eye Lid Canaliculus in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Poor enrollment
Study Start Date
July 14, 2020 (Actual)
Primary Completion Date
January 25, 2023 (Actual)
Study Completion Date
January 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Midwest Eye Institute
Collaborators
Ocular Therapeutix, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This prospective, open-label, single-center, randomized, investigator-sponsored clinical study seeks to investigate: how will pseudophakic patients respond in terms of objective and subjective outcomes, when treated with Dextenza compared to topical prednisolone acetate following gas bubble repair and laser for RD.
Detailed Description
Subjects who have given informed consent and determined to be eligible at screening will be randomized in a 1:1 ratio to DEXTENZA (placed once in the lower punctum) or the use of topical Prednisolone acetate 1% drops (four times daily). They will be observed for a period of 3-months for both pain and inflammation of the eye.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Detachment

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intracanalicular Sustained Release Dexamethasone, 0.4 mg
Arm Type
Experimental
Arm Description
Intracanalicular dexamethasone insert contains 0.4 mg dexamethasone and is designed to provide a sustained and tapered release of therapeutic levels of dexamethasone to the ocular surface for up to 30 days for the reduction of post-surgical inflammation and pain associated with ocular surgery.
Arm Title
topical prednisolone acetate 1%.
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Dextenza
Intervention Description
Intracanalicular sustained release dexamethasone insert 0.4 mg
Intervention Type
Drug
Intervention Name(s)
Prednisolone Acetate
Intervention Description
Topical Prednisolone acetate 1% ophthalmic suspension
Primary Outcome Measure Information:
Title
Mean change in pain score
Description
Average change in pain based on whats reported on the Ocular Pain Assessment
Time Frame
30 Days
Title
Post-op pain scores
Description
Ocular Pain Assessment: Measured on a scale from 0-10 where 0 (minimum) is no pain and 10 (maximum) is extreme pain. High reported pain means a worse outcome.
Time Frame
30 Days
Secondary Outcome Measure Information:
Title
Mean change in anterior chamber cell and flare score
Description
Post op inflammation scores as measured on a scale of 0-4: Anterior Chamber Cell Count (Absence of cell to be defined as a grade of: 0-0.5, 4 being the maximum) and Anterior Chamber Flare Score (0 is the minimum, and 4 is the maximum). High reported cell and flare means a worse outcome.
Time Frame
30 days
Title
Cystoid Macular Edema
Description
Amount of central thickness macular swelling as measured by Optical Coherence Tomography (OCT)
Time Frame
30 days
Title
Best Corrected Visual Acuity
Description
As measured on ETDRS
Time Frame
90 days
Title
Physician Ease of Dextenza insertion
Description
The investigator will grade the level of ease of insertion of the intracanalicular insert on a 0 to 10-point (0 being the minimum and 10 being the maximum) scale with 0 being very easy insertion and 10 being very hard. Difficult insertion means a worse outcome.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pseudophakic Retinal Detachment Age 18 years and older Scheduled for gas bubble repair and laser surgery following retinal detachment Willing and able to comply with clinic visits and study related procedures Willing and able to sign the informed consent form Exclusion Criteria: Patients under the age of 18. Pregnancy (must be ruled out in women of child-bearing age with pregnancy test) Active infectious systemic disease Active infectious ocular or extraocular disease Obstructed nasolacrimal duct in the study eye(s) Hypersensitivity to dexamethasone Patients being treated with immunomodulating agents in the study eye(s) Patients being treated with immunosuppressants and/or oral steroids Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Finnen, MD
Organizational Affiliation
Midwest Medical Advisors, Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Midwest Eye Institute
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Assessing the Efficacy and Safety of DEXTENZA in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment

We'll reach out to this number within 24 hrs